Cleared Traditional

Disposable Enteral Feeding Syringe with Enfit Connector (K193657) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K193657 · Shinva Ande Healthcare Apparatus Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2020
Decision
257d
Days
Class 2
Risk

K193657 is an FDA 510(k) clearance for the Disposable Enteral Feeding Syringe with Enfit Connector. Classified as Enteral Syringes With Enteral Specific Connectors (product code PNR), Class II - Special Controls.

Submitted by Shinva Ande Healthcare Apparatus Co., Ltd. (Zibo, CN). The FDA issued a Cleared decision on September 12, 2020 after a review of 257 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Shinva Ande Healthcare Apparatus Co., Ltd. devices

Submission Details

510(k) Number K193657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2019
Decision Date September 12, 2020
Days to Decision 257 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 130d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PNR Enteral Syringes With Enteral Specific Connectors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
Definition Delivers Nutrition, Medication, Or Hydration Orally Or To A Gastrointestinal Tube Or Extension Set Using Aami/cn3(ps):2014 Compliant Connectors.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
Mike Gu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PNR Enteral Syringes With Enteral Specific Connectors

All 23
Devices cleared under the same product code (PNR) and FDA review panel - the closest regulatory comparables to K193657.
Oral/Enteral Syringe
K210621 · Ningbo Tianyi Medical Appliance Co., Ltd. · Apr 2021
Medline ENfit OTC Feeding Syringe
K202285 · Medline Industries, Inc. · Oct 2020
Enteral Feeding Syringes with ENfit connector (Model: 10 ml
K200557 · Jiangsu Shenli Medical Production Co., Ltd. · Sep 2020
ENFit Oral / Enteral Syringe
K190502 · Jiangsu Caina Medical Co.,Ltd · Aug 2019
Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)
K183540 · Neomed, Inc. · Apr 2019
Enteral Feeding Syringes with Enfit Connectors
K182649 · Jiangsu Kangbao Medical Equipment Co., Ltd. · Nov 2018